IV 

114TH CONGRESS 

1ST SESSION H. RES. 95 

Recognizing the importance of transformative breakthroughs in biomedicine, 

biotechnology, and life sciences in the diagnosis, management, curing, 

and treatment of illness and the existence of a ‘‘Valley of Death’’ in 

biotechnology and life sciences funding that stifles innovation and impedes translational medical research. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 5, 2015 

Mr. VARGAS submitted the following resolution; which was referred to the 

Committee on Energy and Commerce 

RESOLUTION 

Recognizing the importance of transformative breakthroughs 

in biomedicine, biotechnology, and life sciences in the 

diagnosis, management, curing, and treatment of illness 

and the existence of a ‘‘Valley of Death’’ in biotechnology 

and life sciences funding that stifles innovation and impedes translational medical research. 

Whereas cancer, rare and orphan diseases, diabetes, and Alzheimer’s are just a few of a growing number of largescale challenges confronting modern society that can be 

addressed only through the sustained collaboration of 

thousands of highly skilled, dedicated, and independent 

individuals over many years; 


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•HRES 95 IH 

Whereas many promising breakthroughs have occurred in biomedicine in recent years, including gene therapies, molecularly targeted drugs, new modes of medical imaging and 

radiosurgery, biomarkers for drug response, human genome sequencing, and advances in bioinformatics that enabled many of these new applications; 

Whereas biomedicine is far more advanced today than even 

a decade ago is indisputable, but breakthroughs require 

years of translational research at a cost of hundreds of 

millions of dollars and have a substantial likelihood of 

failure; 

Whereas the drug development pipeline is laden with unfavorable probabilities; 

Whereas for every 5,000 to 10,000 compounds that enter the 

drug discovery pipeline, just 250 progress to preclinical 

development, and only one will become an approved drug; 

Whereas the aggregate research and development budget of 

the pharmaceutical industry has nearly doubled from 

$68,000,000,000 in 2002 to $127,000,000,000 in 2010, 

there has been little appreciable impact on the number of 

new drugs approved; 

Whereas Congress must work in a bipartisan fashion to reform the Food and Drug Administration’s (FDA) review 

process for drug development and biomedical innovation 

in order to facilitate expeditious approval of safe and effective new products, better outcomes for patients, and 

more efficient and effective uses of FDA’s limited resources; 

Whereas biomedical innovation has become much more challenging to finance with private and public equity; 


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•HRES 95 IH 

Whereas there is a growing concern within and outside the 

industry that the process of translating biomedical research into effective treatments is obsolete; 

Whereas biotech and life sciences traditional financing vehicles of private and public equity are becoming less effective funding sources because the needs and expectations 

of limited partners and shareholders are not consistent 

with the increasing complexity and risk of biomedical innovation; 

Whereas the lengthy process of biomedical innovation is becoming increasingly complex, expensive, uncertain, and 

fraught with conflicting motivations and public-policy implications; 

Whereas industry professionals frequently refer to the ‘‘Valley 

of Death’’, a steadily widening funding and resource gap 

that currently exists between basic research and clinical 

development, effectively limiting the field of potential 

novel therapies, technologies, and treatments for patients; 

Whereas the life sciences industry needs novel approaches to 

early-stage drug development that better manage risk, 

lower capital cost, improve research effectiveness, create 

diverse portfolios, leverage risk-tolerant capital, and access new capital sources; and 

Whereas innovative financial structures can achieve the necessary grand scale of capital needed to support effective 

diversification of biotech investments and create stable 

and attractive investment opportunities along the development pipeline: Now, therefore, be it 

1 Resolved, That the House of Representatives— 

2 (1) recognizes the importance of transformative 

3 breakthroughs in biomedicine, biotechnology, and life 


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•HRES 95 IH 

1 sciences in the diagnosis, management, curing, and 

2 treatment of illness; 

3 (2) recognizes the need for bipartisan reform of 

4 the Food and Drug Administration (FDA) in order 

5 to facilitate expeditious approval of safe and effec6 tive new products, better outcomes for patients, and 

7 more efficient and effective uses of FDA’s limited 

8 resources; 

9 (3) recognizes the existence of a ‘‘Valley of 

10 Death’’ in biomedicine, biotechnology, and life 

11 sciences funding, a steadily widening funding and re12 source gap that currently exists between basic re13 search and clinical development, effectively limiting 

14 the field of potential novel therapies and drugs for 

15 patients; and 

16 (4) recognizes innovative financial structures 

17 can achieve the necessary grand scale of capital 

18 needed to support translational research and devel19 opment in biomedicine, biotechnology, and life 

20 sciences. 

Æ 


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